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Multi-centric Study (CHEPRALL)

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ClinicalTrials.gov Identifier: NCT01219816
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal prognosis. In this case, allogeneic transplantation is the only curative treatment when patient have obtained a second complete remission (CR. In France, in patients younger than 60 years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied. In older patients (>=60 years)or young patients <= 60 years no eligible for intense chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to avoid too much toxicity but the result is worse in term of CR.

More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey, USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including 15 children, has been published so far reporting the efficacy and the toxicity of Epratuzumab in the setting of ALL in monotherapy, one can observe 8 stable disease, 3 progressions and 4 partial responses. When combining chemotherapy and Epratuzumab, 9CR were observed with acceptable toxicity. Tolerance was acceptable.

The French GRAALL group proposes to test an age-adapted combination of chemotherapy + Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their prognosis, in term of CR, survival and of number of patients eligible for allograft.


Condition or disease Intervention/treatment Phase
B ALL CD22+ Expression Refractory B-ALL Drug: Epratuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Multicenter, Open Label, Prospective to Evaluate Efficacy and Tolerance of a Chemoimmunotherapy With HyperCVAD or Vincristine/Dexamethasone Plus the Anti-CD22 Monovlonal Antobody Epratuzumab for the Treatment of Adult Relapsed/Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients : CHEPRALL Study, a GRAALL Study.
Study Start Date : November 2010
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: Patients under 60 years
Hyper CVAD regimen + Epratuzumab (Cyclophosphamide Vincristine Doxorubicin Dexamethasone)
Drug: Epratuzumab
Combination of chemotherapy + Epratuzumab

Experimental: Patients older than 60 years or < =60 years
Vincristine + Aracytine + Dexamethasone
Drug: Epratuzumab
Vincristine + Dexamethasone + Epratuzumab




Primary Outcome Measures :
  1. complete response rate (CR and CRp)

Secondary Outcome Measures :
  1. Overall response rate (ORR)(CR, CRp and PR)
  2. Overall survival
  3. Disease free survival
  4. CD22 expression after Epratuzumab
  5. Safety and tolerance of Epratuzumab in combination with chemotherapy


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • B-ALL (OMs) with >= 20 % of blasts in bone marrow
  • CD22+ expression >= 30% of the blast population
  • Refractory B-ALL defined by treatment failure after 2 successive courses of induction therapy or relapse < 6 months after first CR
  • First relapse of B-ALL
  • Second relapse or beyond
  • Performance status 0-2
  • Creatinine clearance >= 50 ml/min (Cockroft formula)
  • Serum bilirubine <= 30 µmom/l
  • Written informed consent

Exclusion Criteria:

  • T-ALL
  • Meningeal involvement
  • CD22 expression on tumor cells or < 30%
  • HIV positive
  • Active Hepatitis B or C
  • Left ventricular ejection fraction < 50% in patients <60 years
  • Contra-indication to Epratuzumab
  • Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Participation at the same time in another study in which investigational drugs are used
  • Absence of written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219816


Locations
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France
Angers University Hospital
Angers, France, 49933
University Hospital
Caen, France, 14000
HEnri Mondor Hospital
Creteil, France, 94010
Edouard Herriot Hospital
Lyon, France, 69437
Institut Paoli Calmette
Marseille, France, 13373
Nantes University Hospital
Nantes, France, 44000
Saint Louis Hospital
Paris, France, 75010
St Antoine
Paris, France, 75015
Haut-Leveque Hospital
Pessac, France, 33604
CHU de Poitiers
Poitiers, France, 86021
Purpan Hospital
Toulouse, France, 37509
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Patrice CHEVALLIER, MD Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01219816     History of Changes
Other Study ID Numbers: BRD/10/05-O
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: November 2016

Keywords provided by Nantes University Hospital:
efficacy of Chemo-immunotherapy

Additional relevant MeSH terms:
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Burkitt Lymphoma
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Vincristine
Epratuzumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal